Ensayo randomizado controlado para niñas “Hábitos Saludables, Niñas Saludables”: delineación, protocolo de estudio y resultados iniciales

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

doi:10.1590/0102-311X00136014

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Methodological Issues • Cad. Saúde Pública 31 (7) • Jul 2015 • https://doi.org/10.1590/0102-311X00136014 copiar

Ensayo randomizado controlado para niñas “Hábitos Saludables, Niñas Saludables”: delineación, protocolo de estudio y resultados iniciales

Autoría SCIMAGO INSTITUTIONS RANKINGS

El propósito de este trabajo es describir el diseño del estudio, protocolo y resultados iniciales del programa “Hábitos Saludables, Niñas Saludables”. La intervención se evaluó a través de un ensayo controlado aleatorio en 10 escuelas de São Paulo, Brasil. Las variables se recogieron y evaluaron al inicio del estudio y serán evaluadas tras 7 y 12 meses en base a: índice de masa corporal; circunferencia de cintura; dieta; factores mediadores cognitivos-sociales de nutrición y actividad física; actividad física; sedentarismo; auto-percepción y autoestima. Los resultados iniciales demostraron que el 32,4% y el 23,4% del grupo intervención y control tenían sobrepeso, y para ambos grupos un mayor porcentaje no cumplían con las recomendaciones diarias de actividad física y tiempo dedicado a actividades de ocio. La mayoría de las variables, con excepción edad (p = 0,000) y circunferencia de cintura (p = 0,014), no presentaron diferencias entre grupos. Existe un cierto vacío en la literatura brasileña sobre protocolos de ensayos controlados aleatorios para prevenir la obesidad en jóvenes. Este tipo de trabajos podrían ser una contribución para este campo.

Adolescente; Conducta Alimentaria; Actividad Motora; Obesidad

Activities	Intensity	Description (material)	Behavior change strategy (products)	Target construct (results)
Enhanced PE classes	40x45 minutes	PE classes were delivered by PE teachers for 6 months. The classes included a range of lifetime and lifestyle PA organized into 5 week units. Activities included warm-up/stretching, jogging, dance, skipping rope, and resistance training	Efficient development of specific goals; Information on consequences of health behaviors; Efficient intention formation; Have instructions on the health behaviors; Overcoming barriers; General motivation; Progressive tasks	Self-efficacy; Social support; Intentions; Outcome expectations
PA during recess	14x15 minutes	Participants invited other students to engage in PA sessions during recess. Participants directed the sessions with lifetime PA learned during PE classes, under the PE teacher’s supervision	Friends role modeling or demonstration of behaviors; Progressive tasks; Efficient identification as a role model	Peer support; Self-efficacy; Outcome expectations and expectancies
Weekly nutritional and PA key messages	10x20 minutes	Participants received nutritional and PA messages for 10 weeks, delivered by trained research assistants during recess for 15-20 minutes. The messages were delivered once a week and the topics followed the agenda of the nutrition and PA handbooks, i.e., once every other week on nutrition and PA	Information on nutrition and PA behaviors; Progressive tasks; General motivation; Friends role modeling/friends change; Adequate self-monitoring of the behaviors; Overcoming barriers	Self-efficacy; Social support; Behavioral strategies; Home environment; Outcome expectations and expectancies
Nutrition and PA handbook	10 weeks	The girls received the 10 key nutritional and PA messages through a handbook. The handbook has information, home challenges, and family activities planned to promote nutrition and PA for participants and their families	Information on nutrition and PA behaviors; Adequate self-monitoring of the behaviors; Family support/change	Self-efficacy; Social support; Intentions; Behavioral strategies; Outcome expectations and expectancies
Interactive seminars	3x60 minutes	Girls attended on three interactive workshops delivered by two dietitians, which reinforced the 10 nutrition and PA keys messages. The seminars reinforced the nutrition and PA guidelines and behavioral strategies to support students PA sessions during recess and at home	Information on nutrition and PA behaviors; Adequate self-monitoring of behaviors; Social support/social change; Overcoming barriers	Self-efficacy; Behavioral strategies; Social support; Home environment; Intentions; Outcome expectations and expectancies
Nutrition workshops	3x90 minutes	Girls participated in three workshops delivered by two dietitians that provided dietary information and focused preparation of healthy and inexpensive meals. Activities were planned to develop lifetime nutrition skills that help maintain healthy nutrition and included: energy balance and kilocalories concept, food label information, recipe changes and preparations, the “diet” and “light” concepts, adequate food portion size, food pyramid, and smart food choices	Food and nutrition information; Role modeling or demonstrate on behaviors; Progressive tasks	Self-efficacy; Intentions; Home environment; Outcome expectations and expectancies
Parents’ newsletter	2^nd and 3^rd school terms (4 total)	Parents/caregivers received newsletters describing the study, their daughters’ baseline health behaviors and nutritional status, and encouragement to support their children’s healthy nutrition and PA behaviors at home	Feedback on the girls’ performance; Family support on healthy behaviors; General motivation; Having information on nutrition and PA behaviors	Self-efficacy; Social support; Home environment; Outcome expectations and expectancies
Text messages	2^nd and 3^rd terms twice/week	Twice weekly the girls received text messages encouraging healthy eating, more PA, and less time in sedentary activities. In each intervention school, a text message group was created for more interaction between participants and the moderator. Girls without cell phones received these messages via e-mail	Plan social support/social change; General motivation; Information on nutrition and PA behaviors; Overcoming barriers	Social support; Outcome expectations and expectancies; Self-efficacy
Dietary/ PA diaries	3^rd term	Girls were encouraged to use dietary and PA diaries to encourage goal-setting and self-monitoring behaviors	Efficient self-monitoring; Efficient specific goal-setting	Self-efficacy; Outcome expectations and expectancies; Behavioral strategies

Week	Message
1	Eat fruit and vegetables every day
2	Do physical exercise, respect your limits
3	Eat a healthy breakfast every day
4	Do physical exercise with family and friends
5	Control the size of meal portions and sit while eating
6	Reduce your chair time during recess, after school, and weekends
7	Eat less “junk food” and munch less
8	Identify your excuses for not doing physical exercise
9	Drink water and replace sodas and artificial juices with water, homemade natural fruit juices, and coconut water
10	Make family meals

Variables	Descriptions and example items	Range (items)	ICC (95%CI)
Self-efficacy	Confidence in the ability to overcome barriers to adopt and maintain healthy behaviors
Dietary example	“I find it easy to consume five portions of fruits every day”	5	0.77 (0.51-0.91)
Example of PA	“It’s very hard for me to practice PA when it’s very hot, very cold, or raining”	5	0.62 (0.24-0.84)
Intention	Intentions to adopt healthy behaviors
Dietary example	“Do you plan to choose low-fat foods and/or preparations whenever you have a chance?”	5	0.93 (0.87-0.97)
Example of PA	“Do you plan to practice PA everyday or most days of the week?”	1	–
Social support (friends/family)	Parents’ and friends’ influence, reinforcing healthy behaviors through encouragement and role modeling
Dietary example	“Do your friends support you in choosing healthy foods when you eat meals together?” and “Do your parents sometimes prepare healthy homemade meals dishes?”	5	0.80 (0.61-0.92)
Example of friends’ support for PA	“Do you practice PA with your friends during recess, after school, or on weekends?”	3	0.82 (0.60-0.93)
Example of parents’ support for PA	Do your parents buy things to support your PA?”	4	0.84 (0.67-0.93)
Behavioral strategies	Self-reinforcement of healthy behaviors by setting goals, monitoring behavior, and self-reward
Dietary example	“Do you find ways to make fruits and vegetables more enjoyable?”	6	0.73 (0.49-0.89)
Example of PA	“Do you find ways to make PA more enjoyable?	5	0.92 (0.85-0.97)
Situation	Individual’s perception of their environment
Dietary example	“There are often fruits and vegetables at home”	6	0.91 (0.83-0.96)
Example of PA	“It’s difficult for me to practice PA in my neighborhood due to violence and crime”	6	0.70 (0.42-0.87)
Outcome expectations	Anticipated benefits of healthy behaviors, e.g.: “Healthy eating can reduce my risk for some conditions and diseases”
Dietary example	“Healthy eating can reduce my risk for some conditions and diseases”	5	0.85 (0.72-0.94)
Example of PA	“Regular physical activity helps me manage stress”	5	0.91 (082-0.96)
Outcome expectancies	Value placed on anticipated benefits of healthy behaviors
Dietary example	“How important is it for you to reduce the risk of these conditions and diseases?”	5	0.65 (0.32-0.85)
Example of PA	“How important is it for you to manage stress?”	5	0.69 (0.40-0.87)

	“Healthy Habits, Healthy Girls” (n = 135)		Control group (n = 111)		p-value
	Mean (SD)	ICC (95%CI)	Mean (SD)	ICC (95%CI)	p-value
Age (years)	16.32 (0.78)	16.19-16.45	15.70 (0.82)	15.55-15.86	0.000
Anthropometric measurements
Weight (kg)	59.64 (12.15)	57.63-61.66	55.19 (11.69)	52.99-57.39	0.401
Height (m)	1.62 (0.06)	1.60-1.63	1.60 (0.06)	1.56-1.61	0.486
Waist circumference (cm)	76.41 (10.84)	74.61-78.21	71.46 (10.67)	69.45-73.46	0.014
BMI (kg/m²)	21.81 (4.09)	22.13-23.49	21.44 (3.82)	20.73-22.16	0.247
Total dietary intake (kcal)	2,224.36 (794.48)	2,092.55-2,356.16	2,300.09 (1,012.35)	2,109.66-2,490.51	0.506

	n	%	n	%	p-value

PA classification *
Moderate PA					0.087
Inactive	60	43.2	60	54.1
Insufficiently active	76	53.5	44	39.6
Active	6	4.2	7	6.3
Vigorous PA					0.084
Inactive	104	73.2	94	84.7
Insufficiently active	33	23.2	14	12.6
Active	5	3.5	3	2.7

	n	%	n	%	p-value

Sedentary activities **
Sedentary activities (hours/day)					0.461
< 2	35	24.6	23	20.7
> 2	107	75.4	88	79.3

	n	%	n	%	p-value

BMI classification
Nutritional status					0.102
Underweight	5	3.5	1	0.9
Normal weight	91	64.1	84	75.7
Overweight	33	23.2	22	19.8
Obese	13	9.2	4	3.6

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[1] Correspondence. A. C. B. Leme. Faculdade de Saúde Pública, Universidade de São Paulo. Av. Dr. Arnaldo 715, São Paulo, SP. 01255-000, Brasil. acarol.leme@gmail.com